BROAD SPECTRUM SUNSCREEN SPF 30- titanium dioxide cream 
TRUTH AESTHETICS LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

TITANIUM DAY CREAM SPF 30

Back Panel - Active Ingredient

Active Ingredient

Titanium Dioxide 12.1%

Back Panel - Purpose

Sunscreen

Back Panel - Uses

Back Panel - Directions

Directions

Back Panel - Warnings

Warnings

For external use only.

----------------------------------------------------------

Do not use

on damaged or broken skin

----------------------------------------------------------

When using this product

keep out of eyes. Rinse with water to remove.

-----------------------------------------------------------

Stop use and ask doctor

if rash occurs

----------------------------------------------------------

Keep out of reach of children.

If product is swallowed, get medical help or

contact a Poison Control Center right away.

Back Panel - Inactive Ingredients

Inactive Ingredients: Water/Aqua/EAU, Glycerin, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Cyclopentasiloxane, coconut Alkanes, Caprylic / Capric Triglycerine, Mica (CI77019), Propanediol, Polyhydroxystearic Acid, Stearoxymethicone / Dimenthicone Copolymer, Stearic Acid, Simmondsia Chinensis (Jojoba) Seed Oil, Diisopropyl Dimer Dilinoleate, Alumina, Caprylyl Caprylate / Caprate, Lauryl Glucoside, Phenethyl Alcohol, Oriza Sativa (Rice) Bran Extract, Pyrus Malus (Apple) Fruit Extract, Coco- Caprylate / Caprate, Cichorium Intybus (Chicory) Root Extract, Carbomer, Helianthus Annuus (Sunflower) Seed Oil, Ethylhexylglycerin, Aminomethyl Propanol, Xanthan Gum, Phenoxyethanol, Silica, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol.

Questions or comments?

Within US (866) 660-0740

Front Panel - PDP

Principal Display Panel

TRUFORA

Titanium Day Cream SPF 30

Broad Spectrum Sunscreen

30 ml / 1 fl. oz

BROAD SPECTRUM SUNSCREEN SPF 30 
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69146-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE12.1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
COCONUT ALKANES (UNII: 1E5KJY107T)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
MICA (UNII: V8A1AW0880)  
PROPANEDIOL (UNII: 5965N8W85T)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
JOJOBA OIL (UNII: 724GKU717M)  
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
RICE BRAN (UNII: R60QEP13IC)  
APPLE (UNII: B423VGH5S9)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
CHICORY ROOT (UNII: 090CTY533N)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ROSEMARY (UNII: IJ67X351P9)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69146-301-021 in 1 BOX03/01/2015
1NDC:69146-301-0130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/01/2015
Labeler - TRUTH AESTHETICS LLC (025362874)

Revised: 2/2018
Document Id: 64b7d539-7a5d-aed4-e053-2991aa0a627c
Set id: 837a3726-8582-4c72-a949-82378b93262f
Version: 2
Effective Time: 20180208
 
TRUTH AESTHETICS LLC